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Intellectual Property counsel often face the dilemma of when to file a patent application: as soon as possible, or wait and gather more support? Filing an application “early” helps to avoid anticipatory prior art but if the application is filed too early, the applicant may risk rejections during examination for lack of supportive evidence.
On the other hand, if the application is filed too late, the applicant may lose the priority date. This is especially problematic for biopharma industry applicants where on one hand, these data are often critical for securing a patent; on the other hand, the research and development cycle is long and generating experimental and clinical trial data require significant resources and time to obtain, and business and financial reasons can also render it difficult to predict when the data will become available. Frequently supporting data and related information are not available until af
LAS VEGAS An international pharmaceutical company has agreed to plead guilty in a U.S. court and pay $50 million for deleting and hiding manufacturing records in India during a federal Food and Drug Administration drug purity investigation. Fresenius Kabi Oncology Ltd. “put vulnerable patients at risk,” Brian Boynton, acting assistant attorney general in the […]